FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19936066
·
Received August 8, 2024
Report
- Report Number
- 3003442380-2024-19835
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- July 3, 2024
- Report Date
- December 13, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018365
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1934287- MDR 3003442380-2024-19835 - DEVICE 1 OF 2.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT, THE PATIENT FACED ISSUE OF LEAKAGE WITH 2 INFUSION SETS ON 03-JUN-2024, AFTER BEING IN USE FOR A FEW HOURS. THE LEAKAGE WAS LOCATED AT THE END OF CANNULA, WHICH WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2396078 | AUTOSOFT 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | 6002798 | 05705244018365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |